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BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection

This study has suspended participant recruitment.
(The site is unable to recruit patients.)
Sprim Advanced Life Sciences
Information provided by (Responsible Party):
Bio-K Plus International Inc. Identifier:
First received: September 14, 2010
Last updated: January 14, 2016
Last verified: January 2016
The primary objective of this study is to evaluate the efficacy of BIO-K+ CL1285 for prevention of recurrent Clostridium difficile infection.

Condition Intervention Phase
Recurrent Clostridium Difficile Infection
Dietary Supplement: Lactobacillus acidophilus CL1285® and Lactobacillus casei
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Triple-blind, Randomized, Placebo-controlled, Multi-center Study on the Effect of BIO-K+ CL1285 for Prevention of Recurrent Clostridium Difficile Infection

Resource links provided by NLM:

Further study details as provided by Bio-K Plus International Inc.:

Primary Outcome Measures:
  • Incidence of recurrent Clostridium difficile infection [ Time Frame: 60 days ]

Secondary Outcome Measures:
  • Duration of recurrent diarrhea episodes [ Time Frame: 60 days ]
  • Presence of gastrointestinal symptoms [ Time Frame: 60 days ]
  • Adverse events [ Time Frame: 60 days ]

Estimated Enrollment: 140
Study Start Date: June 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotic
BIO-K+ CL1285
Dietary Supplement: Lactobacillus acidophilus CL1285® and Lactobacillus casei
2 capsules of Lactobacillus acidophilus CL1285® and Lactobacillus casei (50 billion cfu/capsule), consumed once daily for 60 days
Other Name: BIO-K+ CL 1285
Placebo Comparator: Placebo
Dietary Supplement: Placebo
2 capsules of placebo (no live cells), consumed once daily for 60 days


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age 18 years or older
  2. Presence of two or more loose or liquid stools in the 24-hour period prior to initiation of antibiotic therapy
  3. Hospitalized and starting antibiotic therapy for Clostridium difficile infection (CDI) or recurrent Clostridium difficile infection (RCDI), diagnosed with a positive stool culture
  4. Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)
  5. Understand the nature and purpose of the study including potential risks and side effects
  6. Willing to comply with the requirements of the study

Exclusion Criteria:

  1. History of 2 or more clostridium difficile infections at any time prior to the current episode
  2. Presence of severe chronic and/or inflammatory condition
  3. Impaired immunity, e.g. undergoing immunotherapy or chemotherapy
  4. Major gastrointestinal complication, e.g. Crohn's disease or ulcer
  5. Current treatment with nasogastric tube, ostomy, or parenteral nutrition
  6. Use of proton pump inhibitors
  7. Pregnant female or breastfeeding
  8. Eating disorder
  9. History of alcohol, drug, or medication abuse
  10. Daily consumption of probiotics, fermented milk, and/or yogurt
  11. Known allergies to any substance in the study product
  12. Participation in another study with any investigational product within 3 months of screening
  Contacts and Locations
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Please refer to this study by its identifier: NCT01202630

United States, New York
Parker Jewish Institute
New Hyde Park, New York, United States, 11040
Sponsors and Collaborators
Bio-K Plus International Inc.
Sprim Advanced Life Sciences
Principal Investigator: Cornelius J Foley, MD Parker Jewish for Health Care and Rehabilitation
  More Information

Responsible Party: Bio-K Plus International Inc. Identifier: NCT01202630     History of Changes
Other Study ID Numbers: 09-SUS-05-BIK-02
Study First Received: September 14, 2010
Last Updated: January 14, 2016

Keywords provided by Bio-K Plus International Inc.:
Clostridium difficile

Additional relevant MeSH terms:
Communicable Diseases processed this record on May 23, 2017